APO-MIRTAZAPINE TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
31-01-2022
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Aktiv ingrediens:
MIRTAZAPINE
Tilgjengelig fra:
APOTEX INC
ATC-kode:
N06AX11
INN (International Name):
MIRTAZAPINE
Dosering :
30MG
Legemiddelform:
TABLET
Sammensetning:
MIRTAZAPINE 30MG
Administreringsrute:
ORAL
Enheter i pakken:
100
Resept typen:
Prescription
Terapeutisk område:
MISCELLANEOUS ANTIDEPRESSANTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0143928002; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2006-10-03
Preparatomtale
_APO-MIRTAZAPINE (Mirtazapine Tablets) _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-MIRTAZAPINE
Mirtazapine Tablets
15 mg, 30 mg and 45 mg
USP
Antidepressant
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
October 03, 2006
Date of Revision:
January 31, 2022
Submission Control Number: 257508
_APO-MIRTAZAPINE (Mirtazapine Tablets) _
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_Page 2 of 44 _
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RECENT MAJOR LABEL CHANGES
Warnings and Precautions, Skin (7)
01/2022
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................... 4
1
INDICATIONS
..................................................................................................................
4
1.1
PEDIATRICS
...................................................................................................................
4
1.2
GERIATRICS
...................................................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................. 5
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
DOSING CONSIDERATIONS
...........................................................................................
5
4.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
................................................... 5
4.3
ADMINISTRATION
.........................................................................................................
6
4.4
RECONSTITUTION
.........................................................................................................
6
4.5
MISSED DOSE
................................................................................................................
6
5
OVERDOSAGE
.....................................................
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